New England Journal of Medicine Study Evaluates Early Intervention in Moderate Aortic Stenosis

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Summary of  New England Journal of Medicine . https://doi.org/10.1056/NEJMoa2607326
Dr. Philippe Généreux et al.

Points

Cedars-Sinai investigators co-led the international PROGRESS clinical trial randomizing seven hundred forty four patients aged sixty five and older with moderate aortic stenosis and at-risk features.
Participants were assigned to either early transcatheter aortic valve replacement or clinical surveillance with valve replacement performed strictly upon progression to severe stenosis.
At two years, the composite primary endpoint of death or heart-failure events occurred in sixteen point seven percent of early TAVR patients versus twenty three point nine percent in surveillance.
Early TAVR reduced heart-failure hospitalizations by half, dropping to seven point four percent compared to fourteen point nine percent in the clinical surveillance control arm.
Authors concluded that early TAVR provides superior clinical protection against heart failure and death compared to watchful waiting in high-risk moderate aortic stenosis cohorts.

Summary

This multicenter randomized clinical trial evaluated whether early transcatheter aortic valve replacement (TAVR) improves clinical outcomes compared to clinical surveillance in patients with moderate aortic stenosis and at-risk features. Published in The New England Journal of Medicine and presented at TCT 2026 by Cedars-Sinai investigators led by national principal investigator Dr. Raj Makkar, the trial addressed the limitations of traditional management guidelines, which typically defer valve replacement until aortic stenosis becomes severe. Given that moderate disease can impose significant cardiac strain and progress rapidly, the investigation sought to determine whether early intervention reduces the combined incidence of death or heart-failure events.

The PROGRESS trial enrolled 744 patients aged 65 years or older (mean age 78 years) across 74 centers in six countries who presented with moderate aortic stenosis and structural, functional, or symptomatic risk features. Participants were randomly assigned in a 1:1 ratio to undergo TAVR (n=373) or clinical surveillance (n=371) with valve replacement performed only upon reaching conventional severe stenosis indications. At the two-year primary follow-up, the composite endpoint of death or heart-failure events occurred in 16.7% of patients assigned to early TAVR compared to 23.9% of those in the clinical surveillance group. Furthermore, early TAVR cut heart-failure hospitalizations in half, down to 7.4% versus 14.9% in the surveillance cohort, while more than 50% of patients initially assigned to surveillance required delayed valve replacement within the two-year window.

The authors conclude that early TAVR is superior to clinical surveillance in lowering the two-year incidence of death or heart failure in patients with moderate aortic stenosis and high-risk features. While longer-term 10-year follow-up is underway to assess survival and valve durability, these findings suggest that timely intervention before severe stenosis develops can successfully mitigate adverse cardiac events and hospitalizations.

Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2607326?referrer=https%3A%2F%2Fmedicalxpress.com%2F

References

Généreux, P., Makkar, R. R., Pibarot, P., Bax, J. J., Lindman, B. R., Muhammad, K., Oldemeyer, J. B., Pirwitz, M., Barker, C. M., Thourani, V. H., Yadav, P. K., Rodriguez, R., Strote, J., Sakhuja, R., Khalil, R., Sharma, R., Chhatriwalla, A., Mishell, J. M., Kar, B., … Leon, M. B. (2026). Tavr in patients with moderate aortic stenosis with at-risk features. New England Journal of Medicine, NEJMoa2607326. https://doi.org/10.1056/NEJMoa2607326